title: Rooting out institutional corruption to manage inappropriate off-label drug use.
abstract: Prescribing drugs for uses that the FDA has not approved - off-label drug use - can sometimes be justified but is typically not supported by substantial evidence of effectiveness. At the root of inappropriate off-label drug use lie perverse incentives for pharmaceutical firms and flawed oversight of prescribing physicians. Typical reform proposals such as increased sanctions for manufacturers might reduce the incidence of unjustified off-label use, but they do not remove the source of the problem. Public policy should address the cause and control the practice. To manage inappropriate off-label drug use, off-label prescriptions must be tracked in order to monitor the risks and benefits and the manufacturers' conduct. Even more important, reimbursement rules should be changed so that manufacturers cannot profit from off-label sales. When off-label sales pass a critical threshold, manufacturers should also be required to pay for independent testing of the safety and effectiveness of off-label drug uses and for the FDA to review the evidence. Manufacturers should also finance, under FDA supervision, programs designed to warn physicians and the public about the risks of off-label drug use.
authors.affiliation: Professor at Suffolk University Law School and Lab Fellow at the Edmond J. Safra Center for Ethics at Harvard University.
authors.forename: Marc A
authors.initials: MA
authors.lastname: Rodwin
mesh_terms: D003257:Consumer Product Safety; D004345:Drug Industry; D011307:Drug Prescriptions; D004335:Drug and Narcotic Control; D006801:Humans; D007349:Insurance, Health, Reimbursement; D056687:Off-Label Use; D010820:Physicians; D011640:Public Policy; D014481:United States; D014486:United States Food and Drug Administration